FDA 510(k) Application Details - K142984

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K142984
Device Name Light, Surgical, Ceiling Mounted
Applicant SUNNEX, INC.
9319 FORSYTH PARK DRIVE
CHARLOTTE, NC 28273 US
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Contact TISH MENDICK
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 10/16/2014
Decision Date 10/29/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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